Scientific References & Sources
Regulatory guidance and reference-product documentation cited throughout this website
References & Sources
The scientific information on this website is based on public regulatory guidance and official reference-product documentation. Sources are listed below for transparency.
Regulatory Overviews on Biosimilars
Analytical & Quality Guidance
- FDA - Comparative Analytical Assessment & Quality Considerations (Sept 2025)
- EMA - Similar biological medicinal products: quality issues
- ICH - Quality Guidelines hub
- ICH Q6B - Specifications: Test Procedures & Acceptance Criteria
- ICH Q8(R2) - Pharmaceutical Development
- ICH Q9(R1) - Quality Risk Management
- ICH Q5A(R2) - Viral safety evaluation
- EMA / ICH Q5D - Derivation & characterisation of cell substrates
- FDA / ICH Q11 - Development & Manufacture of Drug Substances
- EMA / ICH Q5C - Stability Testing of Biotechnological Products
- EMA - Process validation for biotechnology-derived active substances
- FDA - Process Validation: General Principles and Practices